OTC Monograph User Fees Still On The Table, But Not In Legislation
Executive Summary
FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.
You may also be interested in...
Senate OTC Monograph Bill Boosts Industry Hopes For Passage This Year
Senate legislation to reform the US OTC monograph process mirrors the House draft proposed in January, including a two-year market exclusivity provision for some products. The Consumer Healthcare Products Association says it is working with legislators and is encouraged a reform bill will pass this year.
Senate OTC Monograph Bill Boosts Industry Hopes For Passage This Year
Senate legislation to reform the US OTC monograph process mirrors the House draft proposed in January, including a two-year market exclusivity provision for some products. The Consumer Healthcare Products Association says it is working with legislators and is encouraged a reform bill will pass this year.
Hatch Closing Act: OTC Monograph Reform Legislation?
The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.